Z-2953-2018Class II

Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc...

Name: Z-2953-2018 Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc...
Creator: Sysmex America, Inc.
Published: 2018-07-27
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2018-07-27 / Terminated / root cause: manufacturing process

FDA source

Sysmex America, Inc. began a recall of Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain... on 2018-07-27. FDA classified it as Class II and gives the reason as "The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2953-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-27
Posted: 2018-08-30
Terminated: 2019-07-08
Recalling firm: Sysmex America, Inc.
Product: Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.
Product code: KQC Stains, Hematology
Reason for recall: The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Sysmex, issued a "Product Notifications" letter dated 7/2018 via U.S. mail on 7/27/2018 to the consignees who received the affected lots. The letter was also issued to all other XN-Series customers with registered email addresses with the Sysmex Customer Resource Center via email blast on 7/27/2018 who did not directly receive the affected lots but could have received them through other channels. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1. follow your internal procedures for evaluation of flagged results. 2. Distribute this Product Notification to the appropriate personnel to take the following actions: 3. Upon receipt of unaffected lots of replacement reagent, immediately exchange any affected Fluorocell PLT cartridges currently in use on your analyzer. 4. Discard any remaining affected lots in inventory according to your laboratorys protocols and procedures. 5.Please proceed to the URL: http://pages.sysmex.com/fluorocellrecall.html to complete the Fluorocell Recall Response Form. Confirm receipt and understanding of the Product Notification. Sysmex will replace the quantity of affected lot(s) identified in this Product Notification that are confirmed to be currently in your inventory. If you have any questions concerning this information, please contact Sysmex Quality Assurance Department at [email protected].
Quantity in commerce: 5,168 units
Distribution: Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras, and Nicaragua.
Product codes and lots: Reagent lot numbers: A7125, exp. date 01/9/2019; A7126, exp. date 01/11/2019; A7127, exp. date 01/09/2019, A7128, exp. 01/15/2019; A7129, exp. 01/15/2019; A7130, exp. 01/17/2019; A7131, exp. 01/17/2019, A8003, exp. 01/31/2019; A8004, exp. 01/31/2019; A8005, exp. 02/04/2019; and A8006, exp. 02/04/2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2953-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2953-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-30

Product code KQC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)